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CMC Biologics Analytical Principal Scientist Mission Lead the analytical strategy for early/late programs.
Day-to-day oversight of analytical activities performed at partnered CDMOs and CROs according to latest industry standards and regulatory guidance.
Contribution to set up and development of in-house/outsourced analytical activities
Definition of DS & DP specification according to applicable regulatory guidelines
Prepare the plan for stability studies, reference standard, comparability studies
Prepare and/or review technical documents including method development, method validation, transfer protocols and reports.
Authoring and review of CMC regulatory analytical submissions documents
Work closely with Drug Substance, Drug Product and Characterization Subject Matter Experts to develop analytical, characterization and comparability strategies
Support defining/refining required processes for analytical/characterization activities
Experience with analytical methods for GMP manufacturing
Understanding of the detailed requirements for analytical validation and up to date with current trends
Might include CMC leadership activities.
Education and Experience 15+ years of experience in the pharmaceutical industry focusing in analytical development.
Experience in managing external and internal activities.
Experience in data analysis and statistics.
Experience with NBEs is preferred.
Knowledge of GMP, GLP, GCP, Regulatory processes, a plus.
Strong collaboration skills and experience working with external partners
Communication skills in English written and oral
Values Care: we listen & empathize, we value diverse perspectives & backgrounds and we help each other succeed.
Courage: we challenge the status quo, we take full ownership and we learn from our success & failures
Innovation: we put the patient and customer at the center, we create novel solutions and we empower entrepreneurial mindsets.
Simplicity : we act decisively and avoid over-analysis, we understand why before we act and we are agile & keep things simple.
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